Lifestyle Counseling vs. Clinical Pilates in Women With Temporomandibular Disorders

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 to 45 years
• Women only
• No healthy volunteers
• Adult

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

Official title: Effects of Lifestyle Counseling Versus Lifestyle Counseling Combined With Clinical Pilates in Women With Temporomandibular Disorders

Conditions

Counseling, Health Counseling, Behavior Therapy

Being tested

Life Counselling, Clinical Pilates

Keywords

Temporomandibular Disorders, Lifestyle Counseling, Clinical Pilates, Women's Health, Jaw Function, Functional Limitation

Medical subject headings

Temporomandibular Joint Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Life CounsellingBehavioural

  Participants receive individualized lifestyle counseling focused on stress management, physical activity, and sleep hygiene. Counseling sessions are conducted weekly for 8 weeks, delivered by a trained healthcare professional. The aim is to improve overall health behaviors related to temporomandibular disorder symptoms.

• Clinical PilatesBehavioural

  Participants receive the same lifestyle counseling described above, combined with supervised clinical Pilates sessions. Pilates exercises focus on strengthening the core and improving posture and jaw function, conducted twice weekly for 8 weeks.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Visual Analog Scale (VAS)

   Participants will be asked to mark their pain on a line ranging from 0 (no pain) to 10 (unbearable pain). Pain will be measured at rest and as palpation-induced pain (before and after palpation).

   Measured: Each participant in the group will be evaluated twice. The first assessment will be conducted at the very beginning of the study before any intervention, and the second assessment will be performed after the interventions have been completed.

2. Graded Chronic Pain Scale Version 2.0

   The scale provides a simple, practical, and versatile assessment and is included in the DC/TMD diagnostic criteria. It consists of 8 questions: 3 questions assess pain intensity, 4 questions assess pain-related disability, and 1 question determines the number of painful days. For all questions except the 1st and 5th, participants are asked to rate their pain on a scale from 0 ("no pain") to 10 ("worst pain imaginable").

   Measured: Each participant in the group will be evaluated twice. The first assessment will be conducted at the very beginning of the study before any intervention, and the second assessment will be performed after the interventions have been completed.

3. Jaw Functional Limitation Scale-20

   This is the most widely used self-report questionnaire for assessing jaw functional limitation in TMD. It is included among the recommended measures in the DC/TMD. The scale has three subscales evaluating masticatory function, jaw movements, and social/functional impact. It is scored using a 0-10 Likert scale. The Turkish version has proven reliability and validity (Yıldız, Kocaman, \& Bingöl, 2024).

   Measured: Each participant in the group will be evaluated twice. The first assessment will be conducted at the very beginning of the study before any intervention, and the second assessment will be performed after the interventions have been completed.

4. Maximum Mouth Opening

   This is one of the objective indicators of functional limitation. A normal value is considered to be ≥40 mm. Participants will be asked to open their mouth as wide as possible, and the measurement will be taken using a caliper.

   Measured: Each participant in the group will be evaluated twice. The first assessment will be conducted at the very beginning of the study before any intervention, and the second assessment will be performed after the interventions have been completed.

5. Craniovertebral Angle Measurement

   This is a simple and clinically meaningful postural assessment method that provides information about head posture by measuring the forward position of the head. The angle between the line connecting the tragus (the prominence in front of the ear) and the C7 spinous process (lower part of the neck) and the horizontal plane is measured. A normal value is considered ≥48°. Values less than 48° are recorded as forward head posture (head anterior tilt) (Shaghayeghfard et al., 2016).

   Measured: Each participant in the group will be evaluated twice. The first assessment will be conducted at the very beginning of the study before any intervention, and the second assessment will be performed after the interventions have been completed.

6. Oral Habits Checklist

   Recommended in the DC/TMD protocol, this checklist is used to assess sleep and daytime bruxism as well as other parafunctional habits (e.g., pencil biting, nail biting) (Ohrbach \& Dworkin, 2017).

   Measured: Each participant in the group will be evaluated twice. The first assessment will be conducted at the very beginning of the study before any intervention, and the second assessment will be performed after the interventions have been completed.

7. Generalized Anxiety Disorder-7 Questionnaire (GAD-7)

   This tool is used to screen for generalized anxiety disorder and measure the severity of general anxiety levels. It consists of 7 questions. Participants are asked how often they have experienced anxiety symptoms over the past two weeks. The scoring for each item is as follows: 0 = Not at all, 1 = Several days, 2 = More than half the days, 3 = Nearly every day. The total score ranges from 0 to 21, with the following interpretations: 0-4 = Minimal anxiety, 5-9 = Mild anxiety, 10-14 = Moderate anxiety, and 15-21 = Severe anxiety (Konkan et al., 2013).

   Measured: Each participant in the group will be evaluated twice. The first assessment will be conducted at the very beginning of the study before any intervention, and the second assessment will be performed after the interventions have been completed.

8. Patient Health Questionnaire-15 (PHQ-15)

   Used to assess the frequency and severity of somatic (physical) symptoms and commonly applied for screening somatization disorder. Participants are asked how often they have experienced these symptoms over the past 4 weeks. The questionnaire includes 15 common physical symptoms (e.g., headache, stomach problems, fatigue, sleep disturbances). Each item is scored as 0 = Not at all, 1 = A little, and 2 = A lot. The total score ranges from 0 to 30, with the following interpretations: 0-4 = Low somatic symptom severity, 5-9 = Mild, 10-14 = Moderate, and 15 or higher = Severe somatic symptoms.

   Measured: Each participant in the group will be evaluated twice. The first assessment will be conducted at the very beginning of the study before any intervention, and the second assessment will be performed after the interventions have been completed.

9. Pittsburgh Sleep Quality Index (PSQI)

   Participants' sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The questionnaire consists of 24 items: 19 self-reported questions addressing factors related to sleep quality, and 5 items answered by a spouse or roommate. The 5 spouse/roommate items are clinically evaluated but not included in scoring. The 19 self-report items measure seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Each question is scored from 0 to 3. The total PSQI score (ranging from 0 to 21) is calculated by summing the seven component scores. A total score of 5 or below indicates good sleep quality, while a score above 5 indicates poor sleep quality (Ağargün, Kara, \& Anlar, 1996).

   Measured: Each participant in the group will be evaluated twice. The first assessment will be conducted at the very beginning of the study before any intervention, and the second assessment will be performed after the interventions have been completed.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted15 Jan 2026
2. Study start17 Jul 2025
3. Primary completion17 Oct 2025
4. Study completion15 Jul 2026 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for CounselingStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.